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Regulatory aspects

The FC system has been approved by the CNIL:

as a health data warehouse (EDS): already authorised by the CNIL for the current version of the EDS in December 2020 (Opinion No. 2218579), a new authorisation following a change in the scope of inclusions and data as well as its digital medium was granted by the CNIL on 20 July 21023 (Opinion No. 2229118);
for the matching of CE with the SNDS: following the authorisation of the ARTEMIS research by the CNIL (Opinion N° DR-2020-127), matches of the FranceCoag EDS with the SNDS are planned as part of ancillary research (in these cases, the FranceCoag data are transferred directly from the AP-HM IT support to the platform of the Caisse Nationale d’Assurance Maladie (CNAM), for processing).

Information notes

Inclusion in FranceCoag is made after individual information of the persons and delivery of the adapted information note:

  • during a visit to a FranceCoag partner centre
  • by post
  • by e-mail.

A derogation from the requirement to provide information is made pursuant to article 14-5-b of the RGPD (patients who have died or been lost to follow-up, patients whose data has been collected as part of the SNH project) in the event that the provision of such information proves impossible, would require disproportionate effort or would seriously compromise the achievement of the purposes of the processing operation. In such cases, in accordance with the RGPD, the Data Controller shall take appropriate measures to protect the rights and freedoms, as well as the legitimate interests, of the data subject, including by making the information publicly available, in particular by disseminating on the FC WEB site and by displaying information relating to the data processing.

In addition, general information is posted in waiting rooms and on this website.

The research projects linked to FranceCoag are presented on the open-access part of the WebFC site, providing information on all the studies underway.
See current projects